Cleared Special

K122924 - CRE FIXED WIRE BALLON DILATION CATHETER

K122924 is an FDA 510(k) clearance for CRE FIXED WIRE BALLON DILATION CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code KNQ cleared through the Special 510(k) pathway after a 30-day FDA review.

K122924 · Boston Scientific Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
30d
Days
Class 2
Risk

K122924 is an FDA 510(k) clearance for the CRE FIXED WIRE BALLON DILATION CATHETER. Classified as Dilator, Esophageal (product code KNQ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Marlboro, US). The FDA issued a Cleared decision on October 24, 2012 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5365 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122924

510(k) Number K122924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2012
Decision Date October 24, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KNQ Device Classification - Class 2, Special Controls

Product Code KNQ Dilator, Esophageal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5365
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNQ Dilator, Esophageal

All 35
Devices cleared under the same product code (KNQ) and FDA review panel - the closest regulatory comparables to K122924.
ETHICON ENDO-SURGERYOPTICAL DILATOR
K093236 · Ethicon Endo-Surgery, Inc. · Nov 2009
HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON
K090183 · Cook Endoscopy · Sep 2009
SMART DILATOR
K082995 · Safestitch Medical · Feb 2009
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
K061937 · Cook Endoscopy · Dec 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp · Sep 2006
INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED
K060302 · Cordis Europa, N.V. · Apr 2006
K122924 · CRE FIXED WIRE BALLON DILATION CATHETER
Download PDF FDA Summary Boston Scientific Corp